The Efficacy of Sodium Benzoate as an Adjunctive Treatment in Early Psychosis

Phase 4

Completed

• Conditions: Early psychosis (including schizophrenia, schizophreniform psychosis, delusional disorder, bipolar disorder, psychosis not otherwise specified); Mental Health - Schizophrenia; Mental Health - Psychosis and personality disorders

• Registration Number: ACTRN12615000187549
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-26
• Study Completion: 2018-10-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Aged between 15 and 45 years (inclusive).
2.Fulfil the DSM-IV criteria practice for broadly defined early psychosis, based on the Diagnostic Interview for Psychosis. This includes diagnoses such as schizophrenia, schizophreniform psychosis, delusional disorder, bipolar disorder, psychosis not otherwise specified.
3.Have had the onset of a psychotic disorder within the last two years
4.Have received antipsychotic medications for a period of at least one continuous month within the above two year period.
5.Have a Positive and Negative Syndrome Scale (PANSS) total score of at least 55.
6.Agree to participate, has capacity to consent and able to follow the study instructions and procedures.
7.If under 18 years of age, a parent or legal guardian consents to the young person’s participation.

Exclusion Criteria

1.Known allergies to sodium benzoate (E211) or any part of the formulation of the investigational product.
2.Suspected allergies or known adverse reactions to food preservatives in general.
3.Comorbid physical illnesses that would impair the participants’ ability to complete the trial.
4.People who are unable to understand or communicate in English.
5.For female participant, those currently pregnant, or planning to become pregnant or lactating during the study period
6.Inability to follow the study instructions and procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS) total score [12 week assessment]

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS) subscales [12 week assessment ];Global Assessment of Function (GAF)[12 week assessment];Clinical Global Impression (CGI) [12 week assessment];Hamilton Depression rating Scale-17items (HDRS) [12 week assessment];Physical Activity Questionnaire (PAQ)<br>Outcome measure is level of physical activity.[week 2];Patient Global Impression (PGI)- Improvement<br>Outcome measure is overall patient impression of level of improvement related to the treatment.[week 12]